H52.0
Conditions
Interventions
Group 1: Analysis of the safety and effectiveness of hyperopia after ReLEx SMILE with the VisuMax femtosecond laser at 1 week, 1 month, 3, 6, 9 and 12 months postoperative.
Sponsors
Carl Zeiss Meditec AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Normal corneal topography; - Predicted post-operative keratometry =51 D; - Contact lens wearers must stop wearing their contact lenses before baseline measurements according to local requirements of the clinic; - Patients should be able to understand the patient information and willing to sign an informed consent; - Patients should be willing to comply with all follow-up visits and the respective examinations; - Patients with hyperopia or hyperopia with astigmatism (attempted correction: sphere up to +6.00D, cylinder up to 5.00D and maximum hyperopic meridian up to +7.00D); - The corrected distance visual acuity should be 20/25 or better in each eye pre-operatively; - A difference between cycloplegic and manifest refractions of =1.00 D spherical equivalent in the eye to be treated;
Exclusion criteria
Exclusion criteria: - The patients presenting at least one of the characteristics as described for exclusion criteria in the documentation set of the VisuMax laser keratome ReLEx SMILE option. - Mixed astigmatism - Any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To provide evidence of the safety and effectiveness of the lenticule extraction method SMILE for hyperopia, the following parameter are measured postoperatively at 1 day, 1 week, 1 month, 3 months, 6 months, 9 months and 12 months: uncorrected visual acuity (UDVA) subjective refraction (sphere, cylinder, axis) best corrected visual acuity (CDVA) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include analysis of a patient questionnaire on visual quality and contrast sensitivity evaluated at 3, 6, 9 and 12 months postoperatively compared to preoperatively. Furthermore, the shape of the corneal surface, the side effects and further detailed analyzes of visual acuity and refraction are presented at 1 week, as well as at 1, 3, 6, 9 and 12 months postoperatively. | — |
Countries
China, Czechia, France, Germany, India, United Kingdom
Contacts
Public ContactWalter Sekundo
UKGM - Standort Marburg Augenklinik
Outcome results
None listed